A Culinary Intervention for Bone Health

NCT05197244 | Completed

• 1 other identifier: REB21-1332
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, controlled pilot study to evaluate the feasibility and acceptability of a single 2-hour culinary medicine intervention for bone health among individuals with age-associated low bone mass.

Conditions

Osteoporosis, Age-Related; Osteoporosis Risk

Keywords

osteoporosis; fracture; culinary nutrition; culinary medicine; teaching kitchen; nutrition

Outcome Measures

Primary Outcomes (5)

• Recruitment capacity

  Proportion of total referrals who meet criteria for eligibility screening

  Baseline

• Intervention reach

  Proportion of eligible individuals who agree to participate in study

  Baseline

• Intervention fidelity

  Proportion of participants who complete study procedures

  3 months

• Intervention satisfaction

  Proportion of the intervention group who indicate that they are satisfied with their experience in the culinary medicine class

  3 months

• Intervention mode and dose

  Proportion of the intervention group who would have preferred to attend multiple hands-on culinary medicine sessions rather than a single session

  3 months

Secondary Outcomes (5)

• Readiness to change home cooking patterns

  Immediately post-intervention

• Readiness to change diet

  Immediately post-intervention

• Confidence in ability to change home cooking patterns

  Immediately post-intervention

• Confidence in ability to change diet

  Immediately post-intervention

• Nutrition education needs

  Immediately post-intervention

Other Outcomes (10)

• Meals eaten at home

  3 months

• Home cooking behaviours

  3 months

• Dietary patterns

  3 months

Study Arms (2)

Culinary Medicine Intervention

EXPERIMENTAL

Participants will attend a 2-hour hands-on cooking class in additional to usual care.

Behavioral: Culinary Medicine Intervention

Control

NO INTERVENTION

Participants will receive usual care.

Interventions

Culinary Medicine Intervention BEHAVIORAL

A 2-hour practical culinary medicine program facilitated by a culinary dietitian at a hospital-based teaching kitchen, followed by 3 virtual group follow-up sessions occurring monthly, each lasting approximately 30 minutes. The follow-up sessions will be facilitated by a culinary dietitian and will be conducted using a secure telephone/video conference platform.

Culinary Medicine Intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults referred to local tertiary osteoporosis centre for assessment of age-associated low bone mass or assessment of fracture risk
• Women must be postmenopausal (i.e. documented history of surgical menopause, or at least 12 months since last menstrual period), men must be age ≥45 years
• Self-determined ability to learn in classroom and kitchen environments and a virtual (video) learning environment
• Reliable access to hardware, software, and internet connection required to participate in an interactive virtual (video) conference
• Ability to attend local hospital-based teaching kitchen for culinary medicine intervention
• Willing to participate in a culinary medicine intervention and provide informed consent

You may not qualify if:

• Complex metabolic bone disease or on dialysis for end-stage kidney disease
• Deemed by research team to be unable to learn in a group classroom or kitchen environment
• Unable to communicate in English

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, Canada

Location

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Officials

• Emma O Billington, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm randomized controlled trial

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 19, 2022
• Study Start: July 15, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)